Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1993383238
Device Listing 1993383238
Listing Summary
#
Listing key
1993383238
Premarket submission
K143577
Device
XW-100 Automated Hematology Analyzer, XW QC CHECK
Applicant
Sysmex America, Inc.
Product code
GKZ
Decision date
2015-10-12
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
4531
1950302
1950302
STRECK LLC
1
Y
2026-01-01
7002 SOUTH 109TH ST. La Vista NE US 68128